Clinical Trials Bite Off Chunk of CAR T Therapy Market

About a quarter of lymphoma patients eligible for the cancer treatments are opting for experimental—and free—options instead.

Jul 30, 2019

Despite the recent approval of two cancer therapies that use CAR T cells to treat lymphoma, 25 percent of eligible patients still choose to enter clinical trials instead of undergoing the available treatments. That’s according to insurance claims analyzed by health care consulting firm Vizient, Reuters reports.

Cost may be the driving factor behind patients’ decisions to forgo CAR T therapies already on the market for those still in clinical trials. Approved CAR T interventions Kymriah and Yescarta carry price tags in the hundreds of thousands of dollars, while experimental treatments are typically covered by the trials’ sponsors. “Inadequate inpatient reimbursement, especially for Medicare patients, can be a significant deterrent for hospitals to use commercially approved CAR-Ts,” Jennifer Tedaldi, associate principal at consulting firm ZS Associates, tells Reuters.

CAR T therapies involve extracting a patient’s T cells, engineering them to contain chimeric antigen receptors (CARs), and infusing the cells back into the patient to seek out and destroy cells bearing antigens complementary to the CARs on their surface.

The US Food and Drug Administration approved Kymriah in August 2017 and Yescarta two months later, in October. From May 2017 until December 2018, according to Vizient’s data, 900 patients at 58 hospitals in the US received a CAR T intervention, and 25 percent of those patients did so through a clinical trial. Because this time period stretches back a few months before the cell therapies hit the market, the data include clinical trial patients who may have received the treatments pre-approval.

Medical bills for the patients on experimental cell therapies were half as much as those for patients receiving the approved treatments.

Part of the problem, Reuters explains, is that Medicare, the US government health insurance program for seniors, has not settled its payment structure for CAR T therapies, and private health insurers do not have standard guidelines for coverage.

“CAR-T is a very active space given its potential promise as a one-time curative therapy,” Novartis writes to Reuters in an emailed statement. “As part of our commercial program, we take into account a percentage of patients that are likely to be treated via clinical trials.”